Transcranial focused ultrasound pulsation suppresses pentylenetetrazol induced epilepsy in vivo.
Sin-Guang Chen, Chih-Hung Tsai, Chia-Jung Lin...
https://pubmed.ncbi.nlm.nih.gov/31575487Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID06388707
A Prospective, Open-label, Single-arm, Multi-center Pilot Study Evaluating Safety and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Drug-resistant Temporal Lobe Epilepsy
Led by NaviFUS Corporation · Updated on 2026-04-09
8
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
NaviFUS Corporation
Lead Sponsor
N
NaviFUS US LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and initial effectiveness of low-intensity focused ultrasound (LIFU) neuromodulation using the NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). This pilot study involves adults with epilepsy that has not responded to standard medications, aiming to reduce abnormal brain activity and seizures. Participants will undergo six LIFU treatment sessions over three consecutive weeks. Each treatment uses specific ultrasound exposure settings delivered by the NaviFUS System. Before treatment, patients will be observed and asked to keep a seizure diary for 8 weeks. After completing treatments, there is a 12-week follow-up period to monitor outcomes. Patients may continue their anti-seizure medications throughout the study. Participants will keep a seizure diary throughout the study to track seizure frequency and severity. Researchers will also assess safety by monitoring adverse events for up to 23 weeks. Additional evaluations include EEG scans to observe changes in brain activity, and questionnaires that measure anxiety, depression, and the personal impact of epilepsy. The total study duration includes a 2-month baseline, 3 weeks of treatment, and 12 weeks of follow-up.
CONDITIONS
Brief Title
A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older at the time of enrollment
- Diagnosed with drug-resistant temporal lobe epilepsy, defined by failure of adequate trials of two tolerated anti-epileptic drug schedules
- Have focal-onset seizures with no more than two seizure onset zones, at least one in the mesial temporal lobe
- Experienced at least 4 focal-onset seizures with disabling manifestations in the 8-week baseline and at least one seizure per month
- Have MRI and EEG within the past 3 years, with at least one EEG showing focal epileptiform findings
- Central focused ultrasound exposure region located at least 30 mm beneath the skull bone
- On stable anti-epileptic drug regimen for at least 30 days before enrollment
- Females of childbearing potential must test negative for pregnancy before first treatment and agree to effective contraception during the study
- Able and willing to have hair shaved where the treatment device will be applied
- Able to complete all study questionnaires in English, including with interpreter if needed
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- Primary generalized epilepsy, mixed focal and generalized epilepsy, or history of non-epileptic seizures
- Experienced tonic-clonic status epilepticus within 12 months before enrollment
- Sonication pathway blocked by scars, scalp disorders, metallic implants, or prior craniotomy
- Acute or progressive neurological disorders such as brain tumor, multiple sclerosis, dementia, or vascular lesions
- Implanted electronic devices like pacemakers, defibrillators, deep brain stimulation, except for stable Vagus Nerve Stimulators
- Severe depression, active suicidal behavior, active psychosis, or psychiatric hospitalization within past year
- IQ below 70 based on standardized intelligence testing
- Medical problems limiting study compliance or data interpretation
- Participation in other investigational drug or device studies within 4 weeks before treatment
- Radiofrequency thermocoagulation treatment within 2 months before enrollment
- History of substance or alcohol abuse within the past year (except marijuana)
- Pregnant or breastfeeding women
- Any other condition judged to increase risk or affect study endpoints by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Observation
Duration - 8 weeks
Participants keep an 8-week seizure diary to establish baseline seizure frequency before treatment.
Diary entries throughout the period
Treatment
Duration - 3 weeks
Participants receive 6 focused ultrasound (FUS) treatments over 3 consecutive weeks using the NaviFUS System.
6 treatment visits over 3 weeks
Follow-up
Duration - 12 weeks
Participants are monitored for safety and efficacy outcomes for 12 weeks after treatment completion, continuing seizure diary recordings.
Periodic visits during follow-up
Trial Site Locations
Total: 3 locations
1
Stanford University School of Medicine
Palo Alto, California, United States, 94305
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22903
Actively Recruiting
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Research Team
S
Sheang-Tze Fung, Ph.D.
A
Arthur Lung, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model.
Po-Chun Chu, Hsiang-Yu Yu, Cheng-Chia Lee...
https://pubmed.ncbi.nlm.nih.gov/35581489Pilot study of focused ultrasound for drug-resistant epilepsy.
Cheng-Chia Lee, Chien-Chen Chou, Fu-Jung Hsiao...
https://pubmed.ncbi.nlm.nih.gov/34729772